LUPIN : LAUNCHES RALTEGRAVIR TABLETS 600 MG IN US

• Launch follows US FDA approval of Lupin's abbreviated new drug application for Raltegravir Tablets USP, 600 mg • Lupin is the exclusive first-to-file for this product and is eligible for 180-day generic drug exclusivity • Product is bioequivalent to reference listed drug Isentress HD Tablets, 600 mg of Merck Sharp & Dohme, LLC • Indicated in combination with other antiretroviral agents for treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg • Raltegravir Tablets USP, 600 mg (RLD Isentress HD) had estimated annual US sales of USD 26 million (IQVIA MAT September 2026)

Lupin Limited

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